Phase 2 Randomized Clinical Trial of Luminate® as Compared to Avastin® in the Treatment of Diabetic Macular Edema

• Status: Completed
• Trial end date: 2017-06-13
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 2 Multi center, Randomized, Controlled, Double-Masked Clinical Trial Designed To Evaluate The Safety And Exploratory Efficacy Of Luminate® (Alg-1001) As Compared To Avastin® In The Treatment Of Diabetic Macular Edema

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allegro Ophthalmics, LLC
• Collaborators: Duke University; Trial Runners, LLC
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• Male or female, 18 years of age or older.

• Study eye with clinically significant diabetic macular edema (DME) with central subfield thickness ≥ 350µm on spectral domain OCT

• Best corrected visual acuity (BCVA) of 20/50 to 20/320 ETDRS equivalent (65 letters to 23 letters) in the study eye, with BCVA decrement primarily attributable to DME.

• Treatment naïve, i.e., no previous anti-VEGF treatment in the study eye or no anti-VEGF treatment in the 45 days prior to study enrollment.

• In the investigator's opinion, the subject still has significant intraretinal fluid with room for improvement in both macular edema and BCVA.

• Intra-Ocular Pressure (IOP) is under control (i.e., IOP

≤ 25 mm in the study eye) and study eye is not receiving any IOP lowering drops.

• Willing and able to return for all study visits.

• Able to meet the extensive post-op evaluation regimen.

• Understands and signs the informed consent form.

Exclusion Criteria:

• Active proliferative diabetic retinopathy (PDR) in the study eye such as NVE, NVD, vitreous hemorrhage, or neovascular glaucoma.

• Uncontrolled hypertension defined as systolic >180 mmHg or > 160 mmHg on 2 consecutive measurements or diastolic > 100 mmHg on optimal medical regimen

• Screening HgA1c blood test > 10.0

• Focal laser photocoagulation or intravitreal/periocular steroids of any type in the study eye within the last 90 days prior to study enrollment.

• A history of intravitreal anti-VEGF injection of any type in the study eye within the last 45 days prior to study enrollment.

• History of rhegmatogenous retinal detachment, retinal tear(s), or traction retinal detachments in the study eye.

• Epiretinal membrane and/or vitreomacular traction in the study eye as determined by the central reading center.

• Previous pars plana vitrectomy in the study eye

• Any intraocular surgery in the study eye within the last 90 days prior to study enrollment.

• YAG laser treatment in the study eye in last 30 days prior to study enrollment.

• High myopia in the study eye, with a spherical equivalent of >8.00D at screening

• Other ocular pathologies that in the investigator's opinion would interfere with the subject's vision in the study eye.

• Chronic or recurrent uveitis.

• Ongoing ocular infection or inflammation in either eye.

• A history of cataract surgery complications/vitreous loss in the study eye.

• Congenital eye malformations in the study eye.

• A history of penetrating ocular trauma in the study eye.

• Mentally handicapped.

• Pregnant female, as determined for women less than 60 years old by a positive urine pregnancy test during the screening window.

• Nursing female.

• Currently participating in any other clinical research study.

• Contraindication to the study medication.